Trastuzumab Emtansine(T-DM1) After Trastuzumab Deruxtecan... | NCT06928818

Studies
Trastuzumab Emtansine(T-DM1) After Trastuzumab Deruxtecan(T-DXd) in HER2-Positive Breast Cancer in Korea

NCT06928818

Sponsor

Seoul National University Hospital

Status

Recruiting

Last Update Posted

Apr 23, 2026Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Cancer of Breast
Trastuzumab Emtansine
Trastuzumab Deruxtecan

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 26, 2025Actual

Primary Completion Date

Sep 30, 2028Estimated

Completion Date

Sep 30, 2029Estimated

First Submitted Date

Mar 31, 2025

First Submission Date that Met QC Criteria

Apr 7, 2025

First Posted Date

Apr 15, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 21, 2026

Last Update Posted Date

Apr 23, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
progression-free survival (PFS)	PFS will be assessed by physicians as per routine clinical practice. CT and/or MRI scans will be at baseline and every 2-4 cycles at the treating physician's discretion, reflecting the observational study design.	PFS is defined as the time from treatment initiation to the first occurrence of disease progression or death from any cause, whichever occurs first, assessed up to 12 months.

Secondary Outcomes

Measure	Description	Time Frame
objective response rate (ORR)	• objective response rate (ORR)	12-month
12-month survival rate	12-month survival rate	12-month

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

HER2-positive, advanced (unresectable locally advanced or metastatic) breast cancer
Prior treatment with trastuzumab deruxtecan(T-DXd) in the advanced setting
Intention to treat with Trastuzumab Emtansine (T-DM1) as first therapy upon T-DXd progression

Exclusion Criteria:

Any systemic treatment, other than T-DM1, for breast cancer after trastuzumab deruxtecan (As an exception, patients treated with endocrine agents, not in combination with cytotoxics or antibody-drug conjugates, will be permitted in the study)
Has been previously treated with T-DM1 for advanced breast cancer
Has been previously treated with 4 or more lines of therapy for advanced breast cancer
- Half (50%) or more patients will be those who were treated with second-line trastuzumab deruxtecan (i.e. patients at the later line will be capped).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Signed Informed Consent Form, when the patient is alive and not lost to follow- up.
Age ≥ 19 years old.
Histologically or cytologically confirmed, HER2-positive advanced breast cancer which is either locally advanced precluding resection or metastatic.
Prior treatment with T-Dxd in the advanced setting
Intention to treat with T-DM1 as next therapy upon progression from T-Dxd

Patients who meet any of the following criteria will be excluded from study entry:

Any systemic treatment, other than T-DM1, for breast cancer after T-Dxd (With an exception, endocrine agents not in combination with cytotoxics or antibody-drug conjugates will be permitted in the study)
Has been previously treated with T-DM1 for advanced breast cancer
Has been previously treated with 4 or more lines of therapy for advanced breast cancer

Sampling Method

Probability Sample

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases